ArticleNeurology(R) neuroimmunology & neuroinflammation2018
Cladribine tablets added to IFN-β in active relapsing MS: The ONWARD study.
Article in Neurology(R) neuroimmunology & neuroinflammation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00436826 (A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta), which is not on this map. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-β) Treatment in Multiple Sclerosis Subjects With Active Disease
Who cites it
30 citing papers in PubMed, 62 citations in OpenAlex.
- Treatment-free remission in MS: long-term disease control with cladribine tablets.Journal of neurology · 2026Review
- Insights into adherence to cladribine tablets in the real world in multiple countries: results from patient support programs.Therapeutic advances in neurological disorders · 2026Article
- Optimizing Drug Selection in Children with Multiple Sclerosis: What Do We Know and What Remains Unanswered?Paediatric drugs · 2025Review
- Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025Review
- Twenty Years of Subcutaneous Interferon-Beta-1a for Multiple Sclerosis: Contemporary Perspectives.Neurology and therapy · 2024Review
- Prospective observational study to evaluate treatment satisfaction and effectiveness in patients with relapsing multiple sclerosis starting cladribine tablets (CLADREAL) in Italy.Frontiers in neurology · 2024Article
- Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Updates and advances in multiple sclerosis neurotherapeutics.Neurodegenerative disease management · 2023Review
- Cladribine treatment specifically affects peripheral blood memory B cell clones and clonal expansion in multiple sclerosis patients.Frontiers in immunology · 2023Article
- Disease-modifying therapies for relapsing/active secondary progressive multiple sclerosis - a review of population-specific evidence from randomized clinical trials.Therapeutic advances in neurological disorders · 2023Review
- Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety.Wiener medizinische Wochenschrift (1946) · 2022Review
- Review
- Central nervous system macrophages in progressive multiple sclerosis: relationship to neurodegeneration and therapeutics.Journal of neuroinflammation · 2022Review
- Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS).Journal of central nervous system disease · 2022Article
- Efficacy of Disease Modifying Therapies in Progressive MS and How Immune Senescence May Explain Their Failure.Frontiers in neurology · 2022Review
- [Disease-modifying treatment of secondary progressive multiple sclerosis].Der Nervenarzt · 2021Review
- The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review.CNS drugs · 2021Review
- Skin Reactions in Patients With Multiple Sclerosis Receiving Cladribine Treatment.Neurology(R) neuroimmunology & neuroinflammation · 2021Article
- Real-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Article
- Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets.Frontiers in immunology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and efficacy of cladribine tablets in patients still experiencing active relapsing MS despite interferon (IFN)-β treatment.
methodsA 96-week phase II study, randomizing patients treated with IFN-β to cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β. Patients were to receive cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β in a 2:1 ratio (n = 172) with safety and exploratory efficacy outcomes being assessed.
resultsAdverse events (AEs) and serious AEs were similar across treatment groups, except lymphopenia. Fifty of 124 (40.3%) cladribine/IFN-β recipients vs 0% of placebo/IFN-β recipients reported lymphopenia as an AE, with grade 3/4 lymphopenia (laboratory lymphocyte count < 500 cells/mm
conclusionsIn patients with active relapsing MS despite IFN-β treatment, cladribine tablets 3.5 mg/kg/IFN-β reduced relapses and MRI lesion activity over 96 weeks compared with placebo/IFN-β but led to an increased incidence of lymphopenia. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with active relapsing MS despite IFN-β treatment, cladribine tablets added to IFN-β reduced relapses and MRI lesion activity over 96 weeks and increased the incidence of lymphopenia. CLINICAL
trial registrationNCT00436826.
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.